Cardiac patients who suffer from incapacitating angina despite the maximum doses of medication -- yet who are deemed too frail for coronary bypass surgery or angioplasty -- may find relief through an innovative new laser procedure called Percutaneous Transluminal Myocardial Revascularization (PTMR), now in phase II clinical trials at Cedars-Sinai Medical Center.
Patients experience angina pain in their chest, arms, neck or back because of insufficient blood flow to the heart (much like a garden hose that has been "kinked" and provides only a trickle of water). For PTMR, physicians thread a catheter through the femoral artery, entering the heart's main pumping chamber across the aortic valve. Through this catheter, they insert a fiberoptic laser delivery system, directing the laser's beam to create small channels in the heart muscle wall. The theory is that once these tiny channels have been created, "the heart's response may be to form new capillaries, tiny blood vessels that begin to provide blood flow to those areas that haven't been receiving enough blood flow," explains Norman Lepor, M.D., principal investigator for the study.
PTMR is an outgrowth of Transluminal Myocardial Revascularization (TMR), also awaiting FDA approval, a procedure which employs the same principle, but also requires that the chest wall must first be opened by surgery. If PTMR is proven effective, it would mean a less invasive and possibly less costly procedure for the patient, who eventually may be able to return home the following day.
Candidates for this PTMR study are "patients who don't have options," says Dr. Lepor. "They have been told by their doctor that 'we can't do an operation or angioplasty, and that you're going to have to just take medication and live with your pain.' The exciting thing about PTMR is that it's a unique new way to possibly help these patients."
Sixty-year-old Mary Alice Perez, who on May 27 became Cedars-Sinai's first patient to undergo PTMR, had one overriding reason for trying this experimental procedure. Pain. Not only did her left arm constantly hurt, but she also had an agonizing pain in her neck which she recalls felt "like something was going to burst," and severely limited her activities. About a week before the procedure, the pain had sent her into Cedars-Sinai's Ruth and Harry Roman Emergency Department and then into the Medical Center's Coronary Care Unit. For this mother of four and grandmother of five, there were no other medical options for relief. She had suffered a heart attack when she was only 50, and in 1993, underwent open-heart surgery. Because she also has scleroderma (a multi-system, connective tissue disease), she was not deemed to be a candidate for further invasive procedures or bypass surgery.
She realizes that the relief may not be permanent. Yet, she is delighted that just two months after her procedure, she has been able to resume activities that once overwhelmed her. Once tiring after performing even the most basic of household tasks, Mrs. Perez can now walk on her treadmill for 30-minute intervals. And on June 17, just 21 days after the PTMR procedure, she attended not one but two graduation ceremonies, as she watched her niece graduate from high school and her granddaughter from kindergarten.
Cedars-Sinai already has performed four of the more than 100 PTMR procedures that have been done in clinical trial sites across the U.S. Patients seeking to participate in the study are thoroughly screened and must meet strict eligibility criteria, which include persistence of angina despite maximum medications. For details about the study, call 1-800-CEDARS-1.
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